case management associate

Job Title: Case Management
Associate
Job Duration: 18 months +
Job Location: Indianapolis, IN,
United States
JOB
DETAILS:
Manage adverse event reporting. Stay current regarding FDA and global
regulations with respect to safety reporting and pharmacovigilance. Ensure
regulatory compliance for expedited submission of case reports. Maintain an
understanding of current labeling practices (e. g. , USPI, Core, CIP and
EUSPC). Interact with internal and external customers. Provide support
regarding Global Product Safety (GPS) policies, processes and procedures.
Support product safety surveillance activities.
Education:

• Bachelor's degree(or higher) in a healthcare-related

field or life sciences field or demonstrated equivalent experience is
required

• Demonstrates basic clinical knowledge of various

disease states

• Effective communication skills (verbal and written)
• Demonstrates competency in IT platforms including

databases, Microsoft Office, and CLIENT web based collaboration sites

• Ability to manage multiple concurrent tasks; good

organizational skills, attention to detail; ability to focus for long
periods of time on detailed information; consistently prioritizes work and
makes decisions that comply with applicable timelines

• Effectively analyzes possible solutions to solve a

range of problems

• Effectively responds to customer requirements and

requests

• English language skills — fluent written and verbal

communications

• Knowledge of global regulations with respect to adverse

event reporting

• Knowledge and understanding of GPS policies and

procedures

• Project Management skills
• Ability to learn quickly and adapt to a changing

environment

• Flexibility to adapt to changing priorities
• Demonstrated interpersonal skills; ability to work as

part of a team

• Ability to see the big picture; use logic to solve

problems
Primary Position Responsibilities (major or daily tasks)
Purpose: The purpose of the Associate/Senior Associate/Associate Consultant
Case Management (Case Manager) role is to be responsible for adverse event
report handling. This includes assessing and processing individual adverse
event reports; maintaining awareness of global pharmacovigilance regulations;
ensuring regulatory compliance for expedited submission of individual case
reports; collaborating with internal and external business partners as well as
other duties as assigned. An associate's responsibilities can vary depending on
the needs and focus of a particular team as well as the global case manager
competency model.

Responsibilities:

Adverse Event Case Management:

• Responsible for review, entry, assessment, and

acknowledgement of adverse event reports in the safety database

• Develop an understanding/expertise of pharmacovigilance

regulations

• Comply with internal and external timelines for

managing adverse event data entry and expedited reporting processes as
appropriate

• Creation of a case narrative
• Attempt to obtain follow-up information from external

parties through effective written and oral communications

• Perform typical case management assessment activities

which include (but not limited to): o Select individual adverse event
terms o Code events to appropriate MedDRA terms o Manage and assess
appropriate serious outcome criteria for adverse events o Assess listed
ness - evaluate the case against the appropriate product information o
Determination of whether medical physician safety review is necessary. o
Determine what, if any, follow-up information is needed Global Support:

• Keep current on global regulatory issues and practices

related to GPS

• Understand and apply GPS business practices

Collaboration/Support Internal and External Customers

• Communicate effectively with CLIENT Corporate contacts

from affiliate offices, call center contacts, legal, customer response
teams, and other customer groups

• Understand the confidential nature of company

information and take necessary steps to ensure its protection
bachelors , RN( registered nurse)
case management exp. , adverse event reporting